DePuy Mitek, Inc., a Johnson & Johnson Co. recalls FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving,…

Recall date

November 20, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0658-2016

FDA classification

Class II

Brand / firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Sold / distributed

Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.

Why it was recalled

Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.